Positioning device for eye surgery and procedures

ABSTRACT

The invention provides a positioning device for use in an examination, procedure or surgery of the eye. The positioning device includes an incurvate body with an upper peripheral edge having a first arc length, a lower peripheral edge having a second arc length, and a curved lateral portion therebetween. The lower peripheral edge has an arc length that is longer than the first arc length, as well as one to eight indentations of a size effective to receive a surgical instrument. The incurvate body of the positioning device of the invention is configured to engage at least a portion of the eye posterior to the corneal limbus and beneath which the pars plana is located. The positioning device can also include a handle pivotably attached to the incurvate body. The positioning device can be used to stabilize the eye as well as assist in accurate positioning of instruments during eye examination, procedure or surgery involving the anterior or posterior segment of the eye.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/967,133, filed on Aug. 14, 2013, which claims priority to U.S.provisional patent application Ser. No. 61/682,770, filed Aug. 14, 2012,the contents of which are incorporated herein by reference in theirentirety.

BACKGROUND

The eye is a complex assembly of various tissues that together functionto receive and transmit light to the brain to enable vision. Eyefunction can deteriorate over time due to age, injuries, infections orvarious disease conditions resulting in impaired vision. Numerousprocedures have been developed to treat various eye defects andconditions so as to improve vision. These include, for example, cataractsurgery, refractive surgery including LASIK, trabeculectomy,vitreoretinal surgery, and intravitreal injection of pharmaceuticals.These eye procedures involve repeat placement, removal and exchange ofvarious instruments, which must be accomplished with care, accuracy andprecision while stabilizing the eye in order to avoid inadvertentincising of unintended ocular tissues.

In vitreoretinal surgery, for example, a trocar system is used throughwhich instruments are introduced and exchanged throughout the procedure.Introduction and removal of the trocars during this procedure involve:(1) stabilizing the eye; (2) determining the correct trocar position inpars plana so as to avoid causing trauma to the natural lens or injuryto the retina resulting in tears that can lead to retinal detachment;(3) dragging of the conjunctiva to achieve misalignment of entry pointsin conjunctiva and sclera; (4) removal of blade introducing the trocar;and (5) positioning the irrigation cannula. These steps are performedusing multiple instruments that are exchanged during each step and foreach sclerotomy—in the most common three-port pars plana vitrectomysurgery, these steps are repeated three times. As proper completion ofthese preliminary steps is crucial to initiating eye procedures in asafe and efficient manner, a great deal of time is taken to performthese steps, which therefore, account for a significant portion of thetime involved in the procedure.

Furthermore, certain eye procedures do not require administration ofregional anesthesia (its use can cause discomfort, bleeding orinfection), movement of the eye, which can occur if no regionalanesthesia is used, can interfere with proper placement, use and removalof various instruments thereby presenting a stability and safety issue.

SUMMARY

The invention provides a positioning device that can be used during eyeexams, procedures or surgeries to assist in stabilizing the eye and/orfor placement of various instruments so as to improve efficiency,accuracy, precision and/or safety. The positioning device includes aincurvate body having an upper peripheral edge with a first arc length,a lower peripheral edge with a second arc length longer than the firstarc length, and a curved lateral portion disposed therebetween, thedevice having one to eight indentations on its lower peripheral edge.The upper peripheral edge, curved lateral portion and lower peripheraledge are configured to engage at least a portion of the eye that isposterior to the corneal limbus and beneath which the pars plana islocated. The positioning device can include a handle pivotably attachedto the upper peripheral edge for ease of use.

In one aspect, the invention provides a positioning device for use in aneye procedure that includes an incurvate body having (a) an upperperipheral edge with a first arc length, (b) a lower peripheral edgewith a second arc length that is longer than the first arc length, thelower peripheral edge having one to eight indentations of a sizeeffective to receive a surgical instrument, and (c) a curved lateralportion therebetween. The incurvate body is configured to engage atleast a portion of the eye posterior to the corneal limbus and beneathwhich the pars plana is located.

In some embodiments, the curved lateral portion of the positioningdevice has an angle of about 40° to about 55° relative to a line normalto a plane parallel to the upper and lower edges. In some embodiments,the curved lateral portion of the positioning device has an angle ofabout 45° to about 49° relative to a line normal to a plane parallel tothe upper and lower edges.

In some embodiments, the incurvate body is a frustoconical ring having acircular upper peripheral edge with a first circumference and a circularlower peripheral edge with a second circumference that is larger thanthe first circumference, the circular lower peripheral edge having oneto eight indentations. In some embodiments, the upper peripheral edge ofthe frustoconical ring has an inner circumference that substantiallycoincides with the corneal limbus. In some embodiments, the curvedlateral portion of the frustoconical ring has a pitch that is at leastabout 4 millimeters. In some embodiments, the exterior surface of thecurved lateral portion includes at least one demarcation adjacent to atleast one indentation indicating a position corresponding to about 3.5millimeter from the upper edge. In some embodiments, the demarcation isplaced adjacent to each indentation. In some embodiments, the curvedlateral portion of the incurvate body has a roughened underside. In someembodiments, the lower peripheral edge of the frustoconical ringincludes four indentations, the first and second indentations beingabout 50° apart, the second and third indentations being about 130°apart, the third and fourth indentations being about 50° apart, and thefourth and first indentations being about 130° apart.

In some embodiments, the positioning device includes two mountingmembers disposed on the upper peripheral edge of the frustoconical ringat opposing positions, one of which is about equal distance from thesecond and third indentations on the upper peripheral edge and the otheris about equal distance from the fourth and first indentations on theupper peripheral edge.

In some embodiments, the positioning device includes a handle, one endof which has a two-prong portion, each prong being pivotably attached toa mounting member on the frustoconical ring. In some embodiments, eachprong is attached to a mounting member using a pin inserted throughopenings on the prong and mounting member, through ball-and-socket jointor through a cylindrical-type snap fit joint.

In some embodiments, the lower peripheral edge of the frustoconical ringincludes eight indentations about 45° apart.

In some embodiments, the upper peripheral edge of the frustoconical ringhas an inner circumference that is larger than the circumference of thecorneal limbus.

In some embodiments, the indentations on the lower peripheral edge areU-shaped.

In some embodiments, the indentations are effective to receive asurgical instrument including a trocar, infusion cannula, blade, needle,cotton-tipped applicator, fluid line, fiberoptic light source, light orlaser probe, torpedo light, aspirator, extendable pic, vertical curvedscissors, membrane brush or vitrectomy probe.

In some embodiments, the positioning device is made of material thatincludes metal, plastic or any combination thereof. In some embodiments,the positioning device is made of material that includes martensiticsteel. In some embodiments, the positioning device is made of materialthat includes chromium, nickel, molybdenum, carbon, manganese, titanium,acetal copolymer, high-density polyethylene, nylon, polycarbonate,polyethermide, polyphenyl sulfone, polypropylene, acrylonitrilebutadiene styrene, acrylic or any combination thereof.

In another aspect, the invention provides a positioning device having anincurvate body that is a semi-circular segment of a frustoconical ring,the segment having one to eight indentations on its lower peripheraledge. In some embodiments, the lower peripheral edge of the incurvatebody has four indentations, the second and third indentations beingabout 50° apart, and each of the first and fourth indentations beingabout 32° to about 33° relative to the nearest terminal edge of theincurvate body. In some embodiments, the upper peripheral edge of theincurvate body substantially aligns with a portion of the corneallimbus. In some embodiments, the pitch of the incurvate body is about 4millimeters. In some embodiments, the exterior surface of the curvedlateral portion of the incurvate body includes at least one demarcationadjacent to at least one indentation indicating a position correspondingto about 3.5 millimeter from the upper peripheral edge. In someembodiments, the demarcation is placed adjacent to each indentation. Insome embodiments, the curved lateral portion has a roughened underside.In some embodiments, the lower peripheral edge of the incurvate body hasfour indentations, the second and third indentations being about 50°apart and each of the first and fourth indentations being about 32° toabout 33° relative to the nearest terminal edge. In some embodiments,the indentations on the lower peripheral edge are U-shaped. In someembodiments, a mounting member is disposed on the upper peripheral edgeof the incurvate body at equal distance between the second and thirdindentations. In some embodiments, the positioning device also includesa handle, one end portion of which is pivotably attached to the mountingmember on the incurvate body. In some embodiments, the end portion isattached to the mounting member using a pin inserted through openings onthe end portion of the handle and on the mounting member, throughball-and-socket joint or through a cylindrical-type snap fit joint. Insome embodiments, the positioning device is made of material thatincludes metal, plastic or any combination thereof. In some embodiments,the positioning device is made of material that includes martensiticsteel. In some embodiments, the positioning device is made of materialthat includes chromium, nickel, molybdenum, carbon, manganese, titanium,acetal copolymer, high-density polyethylene, nylon, polycarbonate,polyethermide, polyphenyl sulfone, polypropylene, acrylonitrilebutadiene styrene, acrylic or any combination thereof.

Thus, in some embodiments, the positioning device is used for eyefixation and stabilization, as well as to assist in accurate instrumentpositioning, introduction and/or manipulation during eye examinations,surgeries or procedures. In some embodiments, the positioning device canbe used in anterior segment surgery such as, for example, cataractsurgery and refractive surgery, as well as for vitreoretinal proceduresand posterior segment surgeries such as, for example, virectomy andintravitreal injections.

Any feature or combination of features described herein are includedwithin the scope of the present invention provided that the featuresincluded in any such combination are not mutually inconsistent as willbe apparent from the context, this specification and the knowledge ofone of ordinary skill in the art.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. In case of conflict, thepresent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and notintended to be limiting. Although methods and materials similar orequivalent to those described herein can be used to practice theinvention, suitable methods and materials are described below.

All patents and publications referenced or mentioned herein areindicative of the levels of skill of those skilled in the art to whichthe invention pertains, and each such referenced patent or publicationis hereby incorporated by reference to the same extent as if it had beenincorporated by reference in its entirety individually or set forthherein in its entirety. Applicants reserve the right to physicallyincorporate into this specification any and all materials andinformation from any such cited patents or publications.

Other features and advantages of the invention will be apparent from thefollowing detailed description and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is positioning device 10 with handle 12 terminating in two-prongterminus 14 attached to frustoconical ring 20, as viewed from theunderside of the frustoconical ring 20.

FIG. 2 is an enlarged view of one end of positioning device 10 withfrustoconical, ring 20 as seen from its underside.

FIG. 3 is a perspective view of frustoconical ring 20 with upperperipheral edge 24, curved lateral portion 22 extending to lowerperipheral edge 26, indentation 28 with demarcation 32, and mountingwing 30.

FIG. 4 is a side view of frustoconical ring 20 showing that curvedlateral portion 22 is about 47° with respect to the central axis ofrotation.

FIG. 5 is an enlarged view of one end of positioning device 10 showingthat two-prong terminus 14 is pivotably joined to frustoconical ring 20at mounting wing 30 using pin 16.

FIG. 6 is a side view of positioning device 10 showing the range ofrotation of handle 10 on mounting wing 30 with respect to frustoconicalring 20.

FIG. 7 is an illustration of the upper peripheral edge, lower peripheraledge and lateral surface of a frustoconical ring.

FIGS. 8A-8C are illustrations of the relative positions of afrustoconical ring of the invention with respect to the corneal limbusand the portion of the eye that is posterior to the corneal limbusbeneath which the pars plana is located.

FIGS. 9A-9D are various embodiments of an incurvate body of theinvention and the possible position(s) of the one to eightindentation(s) at the lower peripheral edge of the incurvate body.

FIGS. 10A-10D are cross-sectional or side views of various handletermini and mounting means that can mate to form a swivel joint betweena handle and an incurvate body of the invention to allow the handle tobe pivotably attached to the incurvate body

DETAILED DESCRIPTION

The invention provides a positioning device that can be used in an eyeexamination, eye surgery or other eye procedures. A positioning deviceof the invention includes an upper peripheral edge with a first arclength, a lower peripheral edge with a second arc length longer than thefirst arc length, and a curved lateral wall therebetween, thepositioning device having one to eight indentations on its lowerperipheral edge. The upper peripheral edge, curved lateral wall andlower peripheral edge are configured to engage at least a portion of theeye that is posterior to the corneal limbus beneath which the pars planais located. The positioning device can include a handle pivotablyattached to the upper peripheral edge for ease of use.

Illustrative Embodiment

A specific embodiment of a positioning device of the invention isillustrated in FIG. 1. Positioning device 1 has handle 10 pivotablyattached to an incurvate body with the structure of frustoconical ring20. Handle 10 includes elongated shaft 12 with two-prong terminus 14,through which handle 10 is pivotably joined to frustoconical ring 20.

FIGS. 2-5 illustrate the structure of frustoconical ring 20, which hascurved lateral portion 22, upper peripheral edge 24 and lower peripheraledge 26 with four of indentation 28 (FIGS. 2-4). Upper peripheral edge24 defines an opening having a diameter about commensurate with thecornea (FIG. 7), so that when placed on the eye, the inner circumferenceof upper peripheral edge 24 coincides approximately with the corneallimbus. Curved lateral portion 22 extends about 4 millimeters from upperperipheral edge 24, radially and at an angle of taper of about 47° withrespect to the central axis about which frustoconical ring 20 has arotational symmetry (FIG. 4). The four of indentation 28, each of whichsized to receive a surgical instrument, e.g. about 2.8 millimeters wide,are spaced in a symmetrical pattern on frustoconical ring 20 (FIGS. 2,5). Positioning device 1 also includes demarcation 32 adjacent toindentation 28 marking a position that is about 3.5 millimeters from thecorneal limbus (FIGS. 3, 5).

Frustoconical ring 20 includes two of mounting wing 30 for pivotablyattaching handle 10 (FIGS. 4 & 5). Handle 10 includes elongated shaft 12with two-prong terminus 14, each prong being pivotably mounted onto wing30 using pin 16, which is inserted through an opening at the end portionof each prong and through an opening on each of wing 30 (FIG. 5).Configured as such, handle 10 has an angle of pivot or swivel of about210° (FIG. 6) and can be tilted as needed with respect to frustoconicalring 20 for maximum flexibility and usability.

Components of positioning device 1 are summarized below.

COMPONENTS REF. NO. COMPONENT REF. NO. Handle 10 Frustoconical ring 20Elongated shaft 12 Curved lateral portion 22 Two-prong terminus 14 Upperperipheral edge 22 Demarcation 32 Lower peripheral edge 24 Indentation28 Mounting member 30

Incurvate Body

The incurvate body can be a frustoconical ring as exemplified above inpositioning device 1. As used herein, the term “frustoconical” refers tothe structure formed by the lateral surface of a frustum or truncatedcone (in particular, a right circular cone) in which the plane cuttingoff the apex is parallel to the base of the cone. A frustum or truncatedcone, as illustrated in FIG. 7, has smaller upper base with a circular,upper peripheral edge, a larger lower base with a circular, lowerperipheral edge, and a lateral surface therebetween. Frustum 80, forexample, has lateral surface 82 disposed between smaller upper base 83with circumference 84 and larger lower base 85 with larger circumference86 (FIG. 7).

Similarly, an incurvate body of the invention such as frustoconical ring20 (FIG. 2, 3) has curved lateral portion 22 (with external surface 22 aand an inner or underside surface 22 b) disposed between circular, upperperipheral edge 24 and circular, lower peripheral edge 26. Upperperipheral edge 24 defines a circular opening that expands to its widestat lower peripheral edge 26, and the distance between the upperperipheral edge and the lower peripheral edge being the pitch of thefrustoconical ring. Thus, as used herein, the pitch of an incurvate bodyrefers to the distance between the upper peripheral edge and the lowerperipheral edge of the curved lateral portion.

The curved lateral portion of the incurvate body or frustoconical ringhas an inner or underside surface 22 b and an exterior surface 22 a thatare generally parallel, though the inner or underside surface 22 b canbe roughened by mechanical grinding or polishing, using a grit abrasive,or by electropolish to improve traction with the eye and facilitate gripas needed. As such, the curved lateral portion 22 is generally ofuniform thickness overall. The term “thickness,” as used herein inreference to the curved lateral portion of an incurvate body orfrustoconical ring, refers to the distance between the exterior surfaceand inner or underside surface of the curved lateral portion. Thethickness of the curved lateral portion can be about 0.2 millimeter toabout 1.5 millimeters thick, for example, about 0.3, about 0.5, about0.7, about 0.9, about 1.1, about 1.3, or about 1.5 millimeters thick.

The curved lateral portion of an incurvate body or frustoconical ringhas a fixed angle of taper as illustrated in FIG. 4. The angle of tapercan be between about 40° to about 55°, for example, about 43°, about45°, about 47°, about 49° about 51°, or about 53° relative to thecentral axis of rotation. Thus, the angle between opposing points on theinner lateral surface or across the inner diameter of the incurvate bodyor frustoconical ring can be about 88° to about 100°, for example, about90°, about 92°, about 94°, about 96° or about 98°. The inner surface ofthe curved lateral portion can have any angle of taper that issubstantially congruous with the contour of at least a portion of theeye beneath which the pars planar is located so as to engage and limitmovement of the eye. That is, the angle of taper conforms to thecontours of the eye so as to facilitate engagement with the eye duringuse. To further improve traction, the inner surface of the curvedlateral portion can be subjected to mechanical grinding, mechanicalpolishing, roughening using a grit abrasive, or electropolishing toincrease surface roughness as needed to improve grip.

The incurvate body or frustoconical ring is configured to engage atleast a portion of the eye posterior to the corneal limbus and beneathwhich the pars plana is located. FIGS. 8A-8C illustrates the position ofthe incurvate body or frustoconical ring relative to the cornea when apositioning device of the invention is placed on the eye. Eye globe 40includes cornea 42, corneal limbus 44, and region 46, the approximateregion of the eye surface beneath which the pars plana is located, andgenerally known to those of skill in the art as being about 3millimeters to about 6 millimeters from the corneal limbus.

Components discussed in FIGS. 7-8 are summarized below.

REF. REF. COMPONENTS NO. COMPONENT NO. Frustum 80 Lateral wall 82 Upperbase 83 Upper peripheral edge 84 Lower base 85 Lower peripheral edge 84Eye globe 40 Frustoconical ring 60 Cornea 42 Upper peripheral edge 64Corneal limbus 44 Lower peripheral edge 66 Pars plana region 46Frustoconical ring 70 Trocar cannula 48 Upper peripheral edge 74 Trocarsystem 50 Lower peripheral edge 76

The incurvate body or frustoconical ring engages with at least a portionof region 46. The incurvate body or frustoconical ring can engage withthe portion of region 46 most proximate to the cornea as illustrated inFIGS. 8A and 8B, the portion of region 46 most distal to the cornea, thecenter portion of region 46, or a combination thereof. Accordingly, theincurvate body or frustoconical ring can engage with about one-third ormore of region 46, for example half, two thirds or all of region 46.

In some embodiments, the upper peripheral edge of the incurvate body orfrustoconical ring has an inner circumference that approximates thecircumference of the cornea. As such, the inner circumference can becoextensive or coincides with the corneal limbus when the positioningdevice is placed on the eye (FIGS. 8A & 8B). The diameter of the openingdefined by the upper peripheral edge can be about 11.5 millimeters,about 12 millimeters, or about 12.5 millimeters. In FIG. 8B, the upperperipheral edge of frustoconical ring 60 has an inner circumference thatcoincides with the location of corneal limbus 44. In these embodiments,the pitch of the incurvate or frustoconical ring, i.e. the distancebetween the upper peripheral edge and the nearest point on the lowerperipheral edge, can be, for example, about 4, about 4.5, about 5, about5.5 or about 6 millimeters.

Alternatively, the upper peripheral edge can have an inner circumferencelarger than the circumference of the cornea. For example, frustoconicalring 70 illustrated in FIG. 8C has upper peripheral edge 74 that doesnot coincide with corneal limbus 44, but is posterior to corneal limbus44. Upper peripheral edge 74 defines an opening having a diameter largerthan the diameter of cornea 42. Where the upper peripheral edge has acircumference larger than the circumference of the cornea, thecircumference of the upper peripheral edge can be, for example, about0.5, about 1, about 1.5, about 2, about 2.5, about 3, about 3.5 or about4 millimeters posterior to the corneal limbus.

In some embodiments, the incurvate body can be a segment of anyfrustoconical ring structure described above. As such, the incurvatebody can have the structure of an arc of any arc length that is lessthan a full circle, that is, an arc that extends less than 360°, forexample and without limitation, an arc that extends about 270°, about200°, about 180° or about 120°, so long as the frustoconical ringsegment has the thickness, pitch and curvature substantially asdescribed above for the frustoconical ring. FIGS. 9C and 9D illustratethe structure of various embodiments of an incurvate body of theinvention having a segmented ring structure.

Mounting Member

The incurvate body can optionally have one or two mounting membersdisposed on the upper peripheral edge of the incurvate body forpivotably attaching a handle to the incurvate body.

The mounting member can have any structure to which the handle can bepivotably attached that is known to those of skill in the art. Forexample, the mounting members can be a mounting wing having a flatstructure with an opening configure to accommodate a pin orcylindrical-type snap fit member such as shown in FIGS. 3-5, 7, 10A, 10Cand 10D. Alternatively, the mounting member can include a socketeffective to mate with a spherical knob on the end of the handle to forma ball and socket joint as shown in FIGS. 11B and 10C. In FIG. 10A, avertical cross-sectional view of a prong of the two-prong terminus 14,pin 16 and mounting wing 30 (shown in FIG. 5) is provided. In FIG. 10D,a vertical cross-sectional view of mounting wing 330 is provided toillustrate opening 330 b and the cylindrical-type snap-fit mechanismthat can be used in a device of the invention. Thus, any mechanismsknown to those of skill in the art can be used to pivotably attach thehandle to the incurvate body including, for example, a clevis pin, acotter pin, or a self-locking pin; or a ball-and-socket and/or a snapfitmechanism such as for example, a cantilever beam, cylindrical-type orspherical-type snap fit as further described below and illustratedherein.

In embodiments having two mounting members, the mounting members can bedisposed in opposing positions on the upper peripheral edge of anincurvate body as illustrated in FIGS. 3 and 5. As such, the mountingmembers can be about 180° apart. In these embodiments, a handle having atwo-prong terminus as illustrated in FIG. 5 can be used. In theseembodiments, each prong of the two-prong handle terminus is pivotablyattached to each mounting member using any mechanisms known to those ofskill in the art as discussed above.

Indentations & Demarcations

The incurvate body can have one to eight indentations as illustrated inFIGS. 1-5 and FIGS. 9A-9D. The indentations can be in a symmetrical orasymmetrical pattern, as well as at equidistance apart along the lowerperipheral edge or otherwise.

FIG. 9A illustrates an embodiment of the invention in which theincurvate body is a frustoconical ring having four indentations at thelower peripheral edge. In this embodiment, four indentations can bepositioned as shown in which two indentations are about 50° apart atposition 28-1 and 28-2 on one side, and the other two indentations arealso positioned about 50° apart on the opposing side at position 28-3and 28-4. Arranged as such, position 28-1 is about 130° from position28-4, and similarly, position 28-2 is about 130° from position 28-3.Where the incurvate body includes two optional mounting member 30, eachindentation can be about 65° from the nearest mounting member 30. FIG.9A illustrates the relative positions of one to four indentations insome embodiments of the invention. Thus, where a incurvate body of theinvention has a frustoconical ring structure, the incurvate body canhave (1) an indentation at any of the four positions illustrated in FIG.9A, (2) two or three indentations at any combination of the fourpossible positions illustrated in FIG. 9A, or (3) four indentations atall positions illustrated in FIG. 9A.

FIG. 9B illustrates an embodiment of the invention in which theincurvate body is a frustoconical ring having eight indentations at thelower peripheral edge. In this embodiment, the eight indentations can beevenly positioned about 45° apart at positions 280-1 to 280-8 along thelower peripheral edge. Where the incurvate body includes two optionalmounting member 300, the mounting member 300 can be positioned on theupper peripheral edge at equidistance between any two indentations. FIG.9B illustrates the relative positions of one to eight indentations insome embodiments of the invention. Where a incurvate body of theinvention has a frustoconical ring structure, the incurvate body canhave (1) an indentation at any of the eight positions illustrated inFIG. 9B, (2) two to seven indentations at any combination of the eightpossible positions illustrated in FIG. 9B, or (3) eight indentations atall positions illustrated in FIG. 9B.

In other embodiments where the incurvate body is a frustoconical ring,three indentations can be about 120° apart and four indentations can beabout 90° apart on the lower peripheral edge. In these embodiments,where there are two or three indentations on the lower peripheral edge,the indentations can be about 120°, about 90° or about 45° apart.

FIG. 9C illustrates an embodiment of the invention in which theincurvate body is a frustoconical ring segment of about 180° arc thathas four indentations at its lower peripheral edge. In this embodiment,two of the four indentations can be about 50° apart at about 65° andabout 115° relative to terminal edge 25, i.e. position 28-1 and 28-2,respectively, while the remaining two indentations can be about 32° toabout 33° relative to terminal edge 25, i.e. position 28-5 and 28-6.Alternatively, all four indentations can be about 45° apart as analogousto the positions illustrated in FIG. 9B, in which case the first andlast indentation can be about 22.5° from the nearest terminal edge ofthe incurvate body (while the remaining two indentations can be about67.5° and about 112.5° from a terminal edge 25). Where the incurvatebody includes an optional mounting member 30, mounting member 30 can bepositioned on the upper peripheral edge equidistance between position28-1 and 28-2. Alternatively, two mounting members can be position nearthe terminal edges of the incurvate body. FIG. 9C illustrates therelative positions of one to four indentations in embodiments of theinvention in which the incurvate body is a semi-circular, frustoconicalring segment. In these embodiments, the incurvate body can have (1) anindentation at any of the four positions illustrated in FIG. 9C, i.e.position 28-1, 28-2, 28-5 and 28-6; (2) two or three indentations at anycombination of these four possible positions; or (3) four indentationsat all four of these positions. For example, two indentations can bedisposed 50° apart at position 28-1 and 28-2 on either side of optionalmounting member 30 as shown in FIG. 9D.

In other embodiments where the incurvate body is a frustoconical ringsegment, for example, one of about 180° arc, eight indentations can beabout 20° apart, four indentations can be about 36° apart, and threeindentations can be about 45° apart on the lower peripheral edge. Thus,where there are two or three indentations on the lower peripheral edge,the indentations can be about 20°, about 36°, or about 45° apart.

Components discussed in FIG. 9 are summarized below.

REF. REF. COMPONENTS NO. COMPONENT NO. Frustoconical ring 20-4Frustoconical ring segment 200-4 Optional mounting member 30 Optionalmounting member 30 Indentation position 28-1 Indentation position  28-1Indentation position 28-2 Indentation position  28-2 Indentationposition 28-3 Indentation position  28-5 Indentation position 28-4Indentation position  28-6 Terminal edge 25 Frustoconical ring 20-8Optional mounting member 30 Indentation position 280-1  Indentationposition 280-5 Indentation position 280-2  Indentation position 280-6Indentation position 280-3  Indentation position 280-7 Indentationposition 280-4  Indentation position 280-8 Frustoconical ring segment200-2  Terminal edge 25 Indentation position 280-1 Optional mountingmember 30 Indentation position 280-2

The indentations can have any shape including V- or U-shapes. Theindentation can be of a size sufficient to receive a surgical instrumentthat contacts the sclera during an eye examination, procedure or surgeryas illustrated in FIG. 8A for trocar cannula 48 or trocar system 50.Thus, the indentation can be of a size sufficient to receive, forexample, a trocar, infusion cannula, blade, needle, cotton-tippedapplicator, fluid line, fiberoptic light source, light or laser probe,torpedo light, aspirator, extendable pic, vertical curved scissors,membrane brush, fragmatome and vitrectomy probe. The indentation canhave an arc of, for example, about 2 to about 4 millimeters, forexample, about 2.2, about 2.4, about 2.6, about 2.8, about 3, about 3.2,about 3.4 or about 3.6 millimeters.

The external surface of the curved lateral portion of the incurvate bodycan have one or more demarcations adjacent to the one or moreindentations indicating one or more distances posterior to the corneallimbus, including, for example, a distance of about 1 millimeter, about1.5 millimeters, about 2 millimeters, about 2.5 millimeters, about 5millimeters, about 3.5 millimeters, or any combination thereof.

Handle

The device of the invention can optionally include a handle to assist inplacement of the incurvate body on the eye. The handle can be pivotablyattached to the incurvate body for flexibility in positioning thehandle, as well as improved handling and manipulation of the deviceduring use. The handle can include an elongated shaft having a first endportion configured to pivotably attach to the incurvate body through anoptional mounting member on the upper peripheral edge of the incurvatebody. The first end portion can include a two-prong terminus, each prongbeing configured to pivotably attach to a mounting member on the upperperipheral edge of the incurvate body using any means known to those ofskill in the art. The first end portion or each prong can be a flatstructure with an opening for insertion of a pin as shown in FIG. 10A.The first end portion or each prong on a two-prong terminus can includea spherical knob effective to mate with a socket on the mounting memberas shown in FIG. 10B or 10C to form a ball-and-socket link with theincurvate body. The first end portion or each prong on a two-prongterminus can include a cylindrical-type snap-fit for matting with acylindrical opening in the mounting member as illustrated in FIG. 10D.

Components discussed in FIGS. 10A-10D are summarized below.

REF. REF. COMPONENTS NO. COMPONENT NO. Pin 16 Handle end 214 Handleprong 14 Spherical knob 216 Mounting wing 30 Mounting socket  230bMounting member  230a Handle end 14 Spherical knob 116  Handle end 314Socket of mounting member 130b Cylinder-type snap-fit 316 Mountingmember 130a Mounting member  330a Mounting member  330b opening

Positioning Device of the Invention

A positioning device of the invention can be constructed as a reusabledevice that can be sterilized as is typical for a surgical instrument orconstructed as a single-use or disposable device. A positioning deviceof the invention also can be constructed with a combination of reusableand single-use parts. For example, the incurvate body can be constructedfor single-use to be paired with a reusable handle.

A positioning device of the invention can be constructed of anymaterials known to those of skill in the art including a variety ofmetals or metal alloys including stainless steel, one or more syntheticpolymers or any combination thereof. A positioning device can beconstructed of various types of stainless steel (e.g. dumoxel,austenite, martensitic, ferritic, precipitation-hardening martensitic,duplex, surgical stainless steel), titanium, tungsten carbide, dumostar(steel, chromium, nickel and cobalt) or any combination thereof. Thus, apositioning device of the invention can be made of iron, chromium,carbon, nickel, silicon, manganese, phosphorus, sulphur, aluminum,titanium, molybdenumchrome or any combination thereof. A positioningdevice of the invention can be made of plastics including acetalcopolymer, high-density polyethylene, nylon, polycarbonate,polyethermide, polyphenylsulfone, polypropylene, acrylonitrile butadienestyrene, acrylic or any combination thereof.

Any materials and methods known to those of skill in the art forconstructing medical instruments can be used to manufacture apositioning device of the invention. See, for example, Randy Pell,Surgical Instruments: Converting from Metal to Plastic, in MedicalDevice & Diagnostic Industry, October 2006, Canon Communications, L L C2006, available at www.mack.com/resource/MDDI_Oct06_RPell.pdf (lastretrieved Aug. 10, 2013). See also Helmut Kapczynski, SurgicalInstruments 101 —An Introduction to KMedic Certified Instruments, 1997,available atwww.teleflex.com/en/usa/pdf/KMedic_Surgical_Instruments_101.pdf (lastretrieved Aug. 10, 2013); Surgical Stainless steel, available aten.wikipedia.org/wiki/Surgical_stainless_steel (last visited Aug. 13,2013); and martensite, available at en.wikipedia.org/wiki/Martensite(last visited Aug. 13, 2013). A positioning device of the invention canbe made using any means known to those of skill in the art including byinjection molding. The surface finish on the underside of the incurvatebody can be modified as needed to improve traction with the eye usingany method known to those of skill in the art including by mechanicalgrinding, mechanical polishing or electropolish. A grit abrasive such asaluminum oxide or silicon carbide sandpaper of, for example, 80 to 100grit, 120 grit, 150 grit, 180 grit, can be used to achieve a selectroughness. The desired surface roughness can also be achieved byelectropolish to a range from 150 grit finish to 320 grit finish.

A positioning device of the invention can be used to position andstabilize the eye during various procedures, surgeries and examinations,as well as to enable accurate positioning and manipulation ofinstruments. A positioning device can be used for procedure or surgeryinvolving the anterior or posterior segment of the eye includingstabilization for cataract, LASIK and other refractive eye surgeries,anterior segment taps, intravitreal injections, for example, ofanti-VEGF, steroid, antibiotic or any pharmaceutical to be injectedintravitreally, and for vitreoretinal surgery, in particular, smallgauge vitreoretinal surgery or trans pars plana vitrectomy. Apositioning device of the invention can be used during the preliminarysteps of introducing and placement of surgical instruments such astrocars, illumination instruments and the like, then removed from theeye once the select instruments are in place. Alternatively, apositioning device of the invention can be left on the eye for theduration of the procedure.

The specific embodiments of the invention described above do not limitthe scope of the invention described in the claims.

OTHER EMBODIMENTS OF THE INVENTION

While the invention has been described in conjunction with the detaileddescription, the foregoing description is intended to illustrate and notlimit the scope of the invention, which is defined by the scope of theappended claims. Other aspects, advantages, and modifications are withinthe scope of the following claims.

The specific methods and devices described herein are representative ofpreferred embodiments and are exemplary and not intended as limitationson the scope of the invention. Other objects, aspects, and embodimentswill occur to those skilled in the art upon consideration of thisspecification, and are encompassed within the spirit of the invention asdefined by the scope of the claims. It will be readily apparent to oneskilled in the art that varying substitutions and modifications may bemade to the invention disclosed herein without departing from the scopeand spirit of the invention. The invention illustratively describedherein suitably may be practiced in the absence of any element orelements, or limitation or limitations, which is not specificallydisclosed herein as essential. The methods and processes illustrativelydescribed herein suitably may be practiced in differing orders of steps,and that they are not necessarily restricted to the orders of stepsindicated herein or in the claims.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural reference unless the context clearly dictatesotherwise. Under no circumstances may the patent application beinterpreted to be limited to the specific examples or embodiments ormethods specifically disclosed herein.

The terms and expressions that have been employed are used as terms ofdescription and not of limitation, and there is no intent in the use ofsuch terms and expressions to exclude any equivalent of the featuresshown and described or portions thereof, but it is recognized thatvarious modifications are possible within the scope of the invention asdescribed in the statements of the invention and as claimed. Thus, itwill be understood that although the present invention has beenspecifically disclosed by preferred embodiments and optional features,modification and variation of the concepts herein disclosed may beresorted to by those skilled in the art, and that such modifications andvariations are considered to be within the scope of this invention asdefined by the appended claims. In addition, the invention has beendescribed broadly and generically herein. Each of the narrower speciesand subgeneric groupings falling within the generic disclosure also formpart of the invention.

What is claimed is:
 1. A positioning device for use in an eye procedurecomprising an incurvate body, the incurvate body comprising: (a) anupper peripheral edge having a first arc length, (b) a lower peripheraledge having a second arc length that is longer than the first arclength, the lower peripheral edge comprising one to eight indentations,and (c) a curved lateral portion extending between the upper peripheraledge and the lower peripheral edge, wherein the incurvate body isconfigured to engage at least a portion of the eye posterior to thecorneal limbus of the eye and beneath which the pars plana of the eye islocated; the positioning device further comprising a mounting memberdisposed on the upper peripheral edge, the mounting member comprising anopening for pivotably attaching a handle to the incurvate body.
 2. Thepositioning device of claim 1, wherein the curved lateral portioncomprises an angle of 40° to 55° relative to a line normal to a planeparallel to the upper and lower edges.
 3. The positioning device ofclaim 2, wherein the curved lateral portion comprises an angle of 45° to49° relative to a line normal to a plane parallel to the upper and loweredges.
 4. The positioning device of claim 1, wherein the incurvate bodycomprises a frustoconical ring structure.
 5. The positioning device ofclaim 1, wherein the upper peripheral edge comprises an innercircumference that substantially coincides with the corneal limbus. 6.The positioning device of claim 5, wherein the curved lateral portionextends at least 4 millimeters from the upper peripheral edge to thelower peripheral edge.
 7. The positioning device of claim 6, wherein thecurved lateral portion comprises an exterior surface on which at leastone demarcation is disposed adjacent to at least one indentation of theone to eight indentations indicating a position corresponding to 3.5millimeter from the upper peripheral edge.
 8. The positioning device ofclaim 7, wherein a demarcation is placed adjacent to each indentation.9. The positioning device of claim 1, wherein the curved lateral portioncomprises a roughened underside.
 10. The positioning device of claim 1,wherein the lower peripheral edge comprises four indentations, two ofwhich are 50° apart.
 11. The positioning device of claim 1, wherein thelower peripheral edge comprises eight indentations 45° apart.
 12. Thepositioning device of claim 1, wherein the upper peripheral edgecomprises an inner circumference that is larger than the circumferenceof the corneal limbus.
 13. The positioning device of claim 1, whereinthe indentations are U-shaped.
 14. The positioning device of claim 1,which comprises metal, plastic or any combination thereof.
 15. Thepositioning device of claim 14, which comprises martensitic steel. 16.The positioning device of claim 14, which comprises chromium, nickel,molybdenum, carbon, manganese, titanium, acetal copolymer, high-densitypolyethylene, nylon, polycarbonate, polyethermide, polyphenyl sulfone,polypropylene, acrylonitrile butadiene styrene, acrylic or anycombination thereof.
 17. The positioning device of claim 1, wherein thelower peripheral edge comprises a first, a second, a third and a fourthindentation, and wherein the device comprises two of the mounting memberdisposed on the upper peripheral edge at opposing positions, one ofwhich is about equal distance from the second and the thirdindentations, and the other is about equal distance from the fourth andthe first indentations.
 18. The positioning device of claim 17, furthercomprising a handle, one end of which comprises a two-prong portion,each prong being pivotably attached to one of the two mounting members.19. The positioning device of claim 18, wherein each prong is attachedto one of the two mounting members using a pin inserted through openingson the prong and the respective mounting member, through aball-and-socket joint or through a cylindrical-type snap fit joint. 20.The positioning device of claim 1, wherein the lower peripheral edgecomprises two indentations 50 degrees apart.